Romosozumab Shows Promise for Post-Menopausal Osteoporosis
Published on the Sept. 21, 2016, Rheumatology Network website
By Whitney L. Jackson
Treating post-menopausal osteoporosis patients with romosozumab could improve their long-term bone density and decrease the risk of spine and hip fractures, according to a randomized, multi-center, double-blind, placebo-controlled study.
Currently, there’s a gap in how best to treat post-menopausal women who suffer low bone density thanks to osteoporosis. Using romosozumab could help them ward off both vertebral and all other clinical fractures into older age. Romosozumab is an investigational, bone-forming, monoclonal antibody that binds sclerostin and increases bone formation and decreases bone resportion.
In a Sept. 18 presentation at the American Society of Bone Mineral Research annual conference in Atlanta, lead study author Helen Hayes Hospital rheumatologist Felicia Cosman, M.D., revealed FRAME study investigators wanted to identify a medication that could reverse bone loss and offer preventive care for the future.
The results of this study present “a unique opportunity for patients with osteoporosis who are at high risk for fractures and might be at imminent risk for future fractures. If they have a medication that rapidly increases bone strength and reduces fracture risk, it puts them in a better position for the next year and beyond,” she said.
Participants were post-menopausal women between ages 55 and 90 with osteoporosis. They had bone mineral density T-scores of < -2.5 at total hip or femoral neck. Co-primary endpoints were subject incidence of new vertebral fractures through M12 and M24. Secondary endpoint included clinical (nonvertebral plus symptomatic vertebral) and nonvertebral fracture, and bone mass density.
Of the 7,180 women, 89 percent completed the entire study. They were divided into a placebo group and one that received monthly 210 mg injections of romosozumab. Both groups received 60 mg of denosumab monthly for a year.
According to results, the romosozumab group experienced a 13-percent and 6.8-percent increase in bone density in the spine and hips, respectively, after one year. At the second year, the increase was 17.9 percent for spine and 8.8 percent for hips. Overall, romosozumab decreased new vertebral fracture risk by 73 percent and new clinical fractures by 36 percent.
To read the article at its original location: http://www.rheumatologynetwork.com/news/romosozumab-shows-promise-post-menopausal-osteoporosis
Low Protein and Osteoporosis in Men?
Published on the Sept. 21, 2016, Rheumatology Network website
By Whitney L. Jackson
Low protein intake may be responsible for fractures in older men, according to an observational study that analyzed data from the 2000-2002 Osteoporotic Fractures in Men Study.
Dietary protein is a potentially modifiable risk factor for controlling fractures among older men.
In a Sept. 18 presentation at the American Society of Bone Mineral Research annual conference in Atlanta, lead study author Lisa Langsetmo, M.D., from the University of Minnesota, discussed the investigators’ hypothesis that lower-to-moderate protein intake was associated with an increased fracture risk while high protein intake was not.
“Increased dietary protein intake may be feasible as a low-risk intervention to reduce the risk of hip fracture among older men,” she said.
The study, which included 5,875 men — average age 73.6 years — had two objectives: to assess the association of protein intake with low trauma (trauma < fall from standing height) fracture risk and to assess whether the association between protein intake and fracture risk was mediated by falls, body mass index, bone mineral density, appendicular lean mass or gait speed.
Researchers took baseline protein assessment and excluded men with < 500 kcal/d total energy intake or missing > 10 items. The median was 15.9 percent total energy intake with a range from 14.2 percent to 17.8 percent. They defined low protein intake as the bottom quartile and high intake at the top quartile, Dr. Langsetmo said.
According to the analysis, there were 808 low trauma fractures, excluding head, hands, and feet, over 15 years. Results showed a 16-percent lower hip fracture risk, and an 8-percent lower major osteoporotic fracture risk.
Low protein intake was associated with increased fracture risk (HR=1.28, 95 percent CI, 1.08-1.51) compared to those with moderate intake. High protein intake was not associated (HR=1.00, 95 percent CI, 0.84-1.19). There was a two point change in estimates when they were adjusted for falls, body mass index, appendicular lean mass and gait speed.
The protein intake-fracture risk association was dependent on skeletal site, Dr. Langsetmo said. In addition, while the hip fracture association was strong, there was no such association with vertebral fractures.
To read the article at its original location: http://www.rheumatologynetwork.com/news/low-protein-and-osteoporosis-men
Fracture Assessment Tools Underutilized, Study Shows
Published on the Sept. 19, 2016, RheumatologyNetwork.com Website
By Whitney L. Jackson
Using the fracture assessment tool with older, community-dwelling women can help reduce their risk of hip fracture over time, according to a randomized controlled trial.
Currently, although the cost of fractures is high for both society and individuals, the use of fracture risk tools to identify at-risk patients — and potentially stave off future fractures — is relatively low. The FRAX assessment tool identifies high-risk individuals in primary care environments in an effort to reduce fracture incidence.
The FRAX study was developed by the World Health Organization to evaluate fracture risk based on individual patient models that integrate risk associated with clinical risk factors, as well as bone mineral density at the femoral neck. The FRAX algorithms provide a 10-year fracture probability.
In fact, according to a 2010 study, the National Osteoporosis Foundation Guide recommends treating patients who have a FRAX 10-year score of ≥3 percent for hip fractures or ≥ 20 percent for major osteoporotic fractures to reduce future fracture risks.
In a Sept. 19, presentation at the 2016 American Society of Bone Mineral Research conference, lead author E.V. McCloskey, M.D., from the University of Sheffield in the United Kingdom, discussed a five-year, two-arm study into the efficacy of using the FRAX tool to pinpoint women with osteoporosis who are also at high fracture risk in the community.
Of the 12,483 women identified in primary care environments, 6,233 were randomized into the study’s screening arm. In that group, 898 women (14.4 percent) were identified as high risk using the FRAX tool. By the end of the first year, exposure to osteoporosis medication was higher in the screening group compared to the control group – 15.3 percent versus 4.5 percent, respectively. High treatment uptake occurred in the high-risk group (78.3 percent) at six months.
Results showed the incidence of major osteoporosis fractures – comprising hip, waist, humerus, and clinical vertebral fractures — reduced by 12 percent (2 percent to 21 percent, p=0.018). Screening was associated with a significant reduction in hip fractures (RRR 27 percent, 10 percent – 41 percent, p=0.003).
Based on these findings, researchers wrote, a systematic, community-based screening fracture risk program that uses the FRAX tool in older women can be both feasible and effective in lowering hip fracture risk.
To read the article at its original location: http://www.rheumatologynetwork.com/news/fracture-assessment-tools-underutilized-study-shows
How One Class of Bisphosphonates Could Predict Vertebral Fractures
Published on the Sept. 19, 2016, RheumatologyNetwork.com Website
By Whitney L. Jackson
Using biomarkers to assess the efficacy of existing bisphosphonate drugs in predicting fracture risk could pave the way for improved osteoporosis treatment, according to a new study.
Currently, little analysis exists into how bisphosphonate drugs can relate bone turnover markers to fracture reduction. With the cost of drug development so high — and with the time to get new drugs approved so long — researchers looked into how available drugs can help reduce fracture risk.
In a Sept. 19 presentation at the America Society of Bone Mineral Research conference, lead study author Douglas Bauer, M.D., from the University of California-San Francisco, discussed how biomarkers, such as blood and urine, can help identify how one class of bisphosphonates can predict vertebral — but not non-vertebral — fractures.
Based on the National Institutes of Health Bone Quality project, investigators analyzed data on more than 120,000 participants from 11 clinical trials, including bone turnover markers, dual-energy X-Ray absorptiometry and fracture outcomes. They recorded baseline data from 2,268 individuals with vertebral fractures, 3,286 with non-spine fractures (including 514 hip fractures), and 6,729 N-telopeptide of type 1 collagen fractures.
Researchers compared the mean effect of the bisphosphonate to the placebo over a three-to-four-year period. Results indicate there’s a high statistically-significant relationship between short-term change and bone markers for vertebral fractures compared to the placebo group (p=0.005, r=0.84). However, no such strong relationship exists for non-vertebral fractures. The findings suggest that non-fragile factors, such as falling, come into play for non-vertebral fractures.
For instance, for two hypothetical bisphosphonates with 10 percent versus 30 percent reductions in bone-specific alkaline phosphatase, the model predicted a 19 percent versus 66 percent reduction in vertebral fractures (r2-0.84, p=0.001). The relationship is weaker and not significant for non-vertebral fractures. The comparable risk reductions were 12 percent versus 21 percent (r2=0.06, p=0.27).
Ultimately, Dr. Bauer told Rheumatology Network, the study results can, hopefully, be useful in developing medications for the same bisphosphonate classes and extending the effects to other populations.
“The hope is that this overall effect can be observed in all anti-absorptive medications that will be developed in the future,” Dr. Bauer said. “Hopefully, all this data will be used to fill in predictive efficacy.”
To read the article at its original location: http://www.rheumatologynetwork.com/news/how-one-class-bisphosphonates-could-predict-vertebral-fractures
Who am I?
I’m a seasoned reporter, writer, freelancer and public relations specialist with a master’s degree in international print journalism from The American University in Washington, D.C.
I launched my journalism career as a stringer for UPI on Sept. 11, 2001, on Capitol Hill. That day led to a two-year stint as a daily political reporter in Montgomery County, Md. As a staff writer for the Association of American Medical Colleges, a public relations specialist for the Duke University Medical Center and the public relations director for the UNC-Chapel Hill School of Nursing, I’ve earned in-depth experience in covering health care, including academic medicine, health care reform, women’s health, pediatrics, radiology, and Medicare.
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